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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN DRIVER INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN DRIVER INSTRUMENT Back to Search Results
Catalog Number 6541-4-809
Device Problems Pin (906); Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Material Integrity Problem (2978); Scratched Material (3020)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2015
Event Type  Malfunction  
Event Description

Reused fluted headless pin became stuck on tibial cutting block and staff then broke pin inside triathlon pin driver.

 
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Manufacturer Narrative

Review of the device history records indicates the lot was manufactured and accepted into final stock on 22-jan-2014. There have been no other events for the lot referenced. The device was returned with the broken hex end of the headless pin still in place and could not be removed. The event was confirmed. The event was confirmed as the tip of the pin was still in the headless pin driver. However the root cause could not be determined as the events leading to the fracture of the pin could not be replicated with the returned parts. No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics. If additional information becomes available, this investigation will be reopened.

 
Event Description

Reused fluted headless pin became stuck on tibial cutting block and staff then broke pin inside triathlon pin driver.

 
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Brand NameHEADLESS PIN DRIVER
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4671901
MDR Text Key5687903
Report Number0002249697-2015-01119
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-4-809
Device LOT Number17008
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/22/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/09/2015 Patient Sequence Number: 1
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